Atlas FDA

1977

2,114 FDA 510(k) clearances · Clearance year

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RecordFirmDate
GOAT LAMBDA-LIGHT CHAIN ANTIHUMAN SERUM (K771239)G.D. Searle and Co.1977-08-02
NERVE STIMULATORS (K771237)Rule Medical Instruments, Inc.1977-08-02
SERUM GLUTAMIC PYRUVIC TRANSAMINASE (K770991)Macomb Chemical Co.1977-08-02
WHOLE BLOOD GAS CONTROL (K770950)Dade, Baxter Travenol Diagnostics, Inc.1977-08-02
MONITOR, LIQ. CHROMATOGRAPHY LC-15 UV (K771156)The Perkin-Elmer Corp.1977-08-02
NIMETIC BONDING MATERIAL (K771326)Espe GmbH (Us)1977-08-02
MALE LUER LOCK PLUG (K771339)American Viggo1977-08-02
POLYURETHANE PROD. FOR I.V. NEEDLES (K771125)Devon Industries, Inc.1977-08-02
NIMETIC ETCHING GEL (K771325)Espe GmbH (Us)1977-08-02
LIFECARE EMPTY CONTAINER (K771228)Abbott Laboratories1977-08-02
STERILIZERS, 3100 SERIES TRIM LINE (K771229)Castle Co.1977-08-02
PFISTER-SCHWARTZ STONE RETRIEVER (K771302)V. Mueller O.V. Baxter Healthcare Corp.1977-08-02
CHOLEDOCHOSCOPE SYSTEM (K771367)Richard Wolf Medical Instruments Corp.1977-08-02
LUMI-AGGREGOMETER (K771198)Chrono-Log Corp.1977-08-02
LUBE JEL (K771364)Travenol Laboratories, S.A.1977-08-02
ECONOWRAP PAPER C.S.R. WRAP (K771348)Tower Products, Inc.1977-08-02
MODIFICATION TO KIDNEY DIALYZER (K771349)Erika, Inc.1977-08-02
FLOTATION THERAPY BED (K771264)Aquarius Medical Services1977-08-02
CATHETER THORACIC, AXIOM (K770983)Axiom Medical, Inc.1977-07-29
NEEDLE, CHIBA UNIVERSITY (K771108)Johannah Medical Services, Inc.1977-07-29
GROUP AUDITORY TRAINER HC 431R (K771357)Hc Electronics1977-07-29
POST-AURICULAR HEARING AID HC 880 (K771356)Hc Electronics1977-07-29
ENDOMETRIAL ASPIRATION BIOSPY KIT 182341 (K771149)C.R. Bard, Inc.1977-07-27
INSTATEMP (K770944)H.I. Silverman, D.Sc.1977-07-27
GUSBERG HYSTERECTOMY CLAMP (K771344)J. Sklar Mfg. Co., Inc.1977-07-27
TERUFUSION BLOOD ADMIN. SET (K771209)Terumo America, Inc.1977-07-26
SURGIPULSE HEART RATE MONITOR (K771199)Stryker Corp.1977-07-25
MASK, VAPOR, MONOMER (K770690)Howmedica Corp.1977-07-21
FINGEO EXTENSION SPLINTS (K771287)Fred Sammons, Inc.1977-07-21
SEQUENTIAL PRESSURE CUFF (K771083)Gaymar Industries, Inc.1977-07-21
CHOLESTEROL KIT (K771067)Environmental Chemical Specialties1977-07-21
UNIPAK URIC ACID (K771088)Harleco1977-07-21
RM VI-HV (K771157)Rich-Mar Corp.1977-07-21
UNIPAK CHOLESTEROL (K771093)Harleco1977-07-21
CLINICARD UV AMYLASE CHEMISTRY (K771131)Harleco1977-07-21
DIAG. OZYRATE GLUCOSE REAG. SET (K771059)J.T. Baker Chemical Co.1977-07-21
TISSUE CULTURE MEDIA W/HEPES BUFFER (K770764)Microbiological Assoc.1977-07-21
UNIPAK BUN (K771087)Harleco1977-07-21
ORTHOSCOPE (K771200)Stryker Corp.1977-07-21
UNIPAK GLUCOSE (K771091)Harleco1977-07-21
DATA REDUCTION SYSTEM, DP-3000 (K770877)Beckman Instruments, Inc.1977-07-21
UNIPAK TOTAL & DIRECT BILIRUBIN (K771092)Harleco1977-07-21
FRACTURE CAST BRACE KIT, PLASTIC (K770898)Chase Mfg. Co.1977-07-21
DIAG. CONDUCTA RATE BUN REAG. SET (K771060)J.T. Baker Chemical Co.1977-07-21
CENTRIFICHEM TRIGLYCERIDE CALI. STD. (K771215)Union Carbide Corp.1977-07-21
HEMOGLOBIN ANALYZER & PERFORM. CHECK SET (K771101)The Dow Chemical Co.1977-07-21
PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY (K770942)Pharmaseal Div., Baxter Healthcare Corp.1977-07-21
UNIPAK ALBUMIN (K771094)Harleco1977-07-21
WALPEO TABLH (K771202)Walpeo Corp.1977-07-21
CAST BRWM, FRACTURE (K770900)Chase Mfg. Co.1977-07-21
UNIPAK TOTAL BILIRUBIN (K771089)Harleco1977-07-21
FRACTURE CAST BRACE, POLY (K770899)Chase Mfg. Co.1977-07-21
LAS-R TEST PROGRAM (K771226)Hyland Therapeutic Div., Travenol Laboratories1977-07-21
CENTRIFICHEM TRIGLYCEOIDE CALI, STD. SET (K771216)Union Carbide Corp.1977-07-21
JAMAR DYNAMOMETEO BK-7498 (K771288)Fred Sammons, Inc.1977-07-21
CHROMATOGRAPHY ANALYSIS SYS, MODEL 8500 (K770827)Varian Assoc., Inc.1977-07-21
PACEMAKER & CARDIAC LEAD, BIPOLAR (K771262)Arco Medical Products Co.1977-07-21
QUADRIPLEGIC MEAT KNIFE (K771274)Fred Sammons, Inc.1977-07-21
CPK-INT TEST (K771154)Hycel, Inc.1977-07-21
CATHETERS, DRAINAGE (K771048)Axiom Medical, Inc.1977-07-19
TRAY, BLOOD GAS, ARTERIAL, #4014 (K770850)Concord Laboratories, Inc.1977-07-15
TOOTHBRUSH, PEDODONTIC, #0126-0188-00 (K771183)Hoyt Laboratories1977-07-15
BIOBOND MASTER STAIN AND GLAZE KIT (K771179)Dentsply Intl.1977-07-15
SILICONE IMPRESSION MATEOIAL (K771248)Interstate Dental Co., Inc.1977-07-15
ALARM SYS FOR NITROUS OXIDE SYS. (K771246)Star Dental Mfg. Co.1977-07-15
CB600, TURBINE CONTROL BOL (K771252)Litton Dental Products1977-07-15
NF DEVICE (K770517)Rpr, Inc.1977-07-15
CARDIOZYME CK-TOTAL REAGENTS (K770972)Dade, Baxter Travenol Diagnostics, Inc.1977-07-15
FLAME PHOTOMETER MOLEL 4600, KDA (K770824)American Monitor Corp.1977-07-15
UNITED SKIN BARRIER (K770982)Howmedica Corp.1977-07-15
CHOLINESTERASE REAGENT SYSTEM (K771024)American Monitor Corp.1977-07-15
CORE MATERIAL (K771247)Star Dental Mfg. Co.1977-07-15
HU:500, HYGIENASSIST (K771251)Litton Dental Products1977-07-15
PHENYTOIN ANALYTICAL TEST PACKS (K771233)E.I. Dupont DE Nemours & Co., Inc.1977-07-15
TMA BICARBONATE DILUENT (K771044)Hyland Therapeutic Div., Travenol Laboratories1977-07-15
DESENSITRON (K771130)Parker Laboratories, Inc.1977-07-15
LIPOPROTEIN PROFILING SYSTEM (K770948)Beckman Instruments, Inc.1977-07-15
ACCU. CROWN COLD CURE (K771254)Briar Cliff, Inc.1977-07-15
JOY LIGHT (K771249)M.D. Intl., Inc.1977-07-15
WILL-CERAM W-2 (K771145)Williams Gold Refining Co., Inc.1977-07-15
RID PLATES & INTENSI. FOR HUMAN IGE ETC (K771238)G.D. Searle and Co.1977-07-15
PERIODONTIC TOOTHBRUSH, #0126-0190-00 (K771185)Hoyt Laboratories1977-07-15
NEKO CERAMIC CONVENIENCE CROWNS (K771128)Sterndent Corp.1977-07-15
HERITAGE SPECIAL ALLOY (K771110)Howmedica Corp.1977-07-15
PASTES, RESTORATIVE & TINTED, DEBTAL (K771119)Espe Dental Products1977-07-15
ACRY TEMP (K771257)Interstate Dental Co., Inc.1977-07-15
TOOTHBRUSH, ORTHODONTIC, #0126-0189-00 (K771184)Hoyt Laboratories1977-07-15
MICRO BI-POLAR FORCEPS #39-200 (K771186)Edward Weck, Inc.1977-07-15
SUPERFINE DIAMONDS (K771214)Den-Mat Corp.1977-07-15
AV FISTULA NEEDLE SET (K771206)Terumo America, Inc.1977-07-15
TRENDAR (K771000)Hi Chem, Inc.1977-07-15
T3 CLASP RIA KIT (K771142)E. R. Squibb & Sons, Inc.1977-07-14
REVERSING CLICK GENERATOR RCG6 (K771188)Teca, Inc.1977-07-14
PORTO-VAC (K771071)Cpac, Inc.1977-07-14
AUTO TOTAL PROTEIN FOR ANALYZER (K770887)Harleco1977-07-14
POUCHES, PEEL OPEN, BREATHABLE (K771032)Surgicot, Inc.1977-07-14
ULTRAZYME PLUS GOT (K770883)Harleco1977-07-14
RHODAMINE-CONJUGATED ANTISERUM (K771144)Kent Laboratories, Inc.1977-07-14
SURGICAL HEAD DRAPE, DISP. (K771136)Procter & Gamble Mfg. Co.1977-07-14
DOPPLER (UTD-5 & UTD-6) (K771211)Terumo America, Inc.1977-07-14
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Every clearance here is in the API, with alerts when new ones post.